News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

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News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Expanded universal screening would increase costs to the healthcare system; would the healthcare system shortchange clinical labs inadequate reimbursement for the increased number of screening tests?

Separate recommendations that call for widespread, regular screening for HIV and hepatitis C can be considered to be good news/bad news stories for the clinical laboratory testing industry. That’s because the benefits in patient health are likely to incur additional costs for which the healthcare system is not likely to fully reimburse the medical laboratories performing these screening tests.

To improve detection and diagnosis of HIV, a story published in Reuters reported that the U.S. Preventive Services Task Force (USPSTF) will issue a new recommendation to make human immunodeficiency virus (HIV) screening a standard practice. Experts believe that such a strategy would fundamentally change how the virus is detected and treated.

“HIV is in the general population now,” declared Lisa Fitzpatrick, M.D., M.P.H., Director of the United Medical Center, an HIV clinic in Washington DC. “All healthcare providers have a responsibility to find cases of HIV because we don’t know where they are,” she added.

Early Detection and Treatment Help Prevention of AIDS

The new guideline represents a shift from the task force’s 2005 position. At that time, the USPSTF left the decision of expanded HIV screening up to doctors. In 2006, the CDC, The American College of Physicians, and the HIV Medicine Association advocated testing everyone between the ages of 13 and 64 at least once, Reuters reported.

Proposals to expand HIV screening and HCV screening across the entire population are finding favor at the U.S. Preventive Services Task Force and the Centers for Disease Control and Prevention, respectively. These proposals would definitely increase the volume of clinical laboratory testing required to screen larger numbers of individuals within the general population. (Photo by housingworks.com)

Proposals to expand HIV screening and HCV screening across the entire population are finding favor at the U.S. Preventive Services Task Force and the Centers for Disease Control and Prevention, respectively. These proposals would definitely increase the volume of clinical laboratory testing required to screen larger numbers of individuals within the general population. (Photo by housingworks.com)

Two separate government health programs are stepping forward with recommendations. In recent years, new scientific evidence  is showing that early diagnosis and treatment of HIV patients translates into better prevention. In fact, early treatment of HIV has been reported to cut transmission risk to uninfected partners by 96%.

Pathologists and clinical laboratory managers will be interested to learn that the USPSTF is expected to recommend a one-time screening of the general population. This would be followed up by yearly testing in communities where the disease is more prevalent. Experts believe that such a strategy would prevent approximately 212,000 new HIV infections. They also believe it would lead to healthcare savings in the long-term.

An estimated 1.2 million people live with HIV/AIDS, the Reuters story stated. According to the U.S. Centers for Disease Control and Prevention (CDC), 20% of those are unaware that they are infected. Every year, nearly 60,000 new cases of HIV are reported.

But, like everything, there is a cost to find and treat these HIV-infected individuals. According to the Reuters piece, Stanford University researchers estimated that the cost of expanding HIV testing to the general U.S. population would be $27 billion over a 20-year period.

The cost of adding an HIV screening to a patient’s routine blood exam would be around $1.50. However, the question medical laboratory professionals will ask is this: would the U.S. healthcare system come up with more than $2 billion per year to reimburse labs for the cost of the additional volume of HIV testing? Some pathologists would argue that the healthcare system is likely to squeeze the medical laboratory test fees paid to labs to a level that would not compensate a clinical lab for all its fully-loaded costs to perform those HIV screening tests.

The USPSTF screening recommendation for HIV is expected to be made available for public comment before the end of the year.

CDC Wants Universal Testing for Hepatitis C for Certain Age Groups

There is a similar story for HCV. New guidelines from the CDC  recommend expanded screening for hepatitis C, another Reuters story reported. HCV is a disease that kills more than 15,000 Americans every year. CDC officials believe the relatively inexpensive blood test will address the largely preventable consequences of the disease. Newly available therapies can cure around 75% of hepatitis C infections, the Reuters journalist noted.

“Everyone age 47 to 67 who hasn’t already been tested for hepatitis C should be tested once,” stated Thomas R. Frieden, M.D., M.P.H., Director of the CDC. This represents a departure from previous CDC recommendations of hepatitis C testing, which recommended HCV testing only for people with certain known risk factors.

The CDC estimates that about 3.2 million people in the U.S. are chronically infected with hepatitis C. According to Reuters, experts expect the new hepatitis C recommendations to:

• identify more than 800,000 infections,

• prevent 100,000 cases of cirrhosis,

• prevent more than 50,000 cases of liver cancer, and

• save more than 120,000 lives.

Only under certain circumstances would a large expansion of routine screening for HIV and hepatitis C be good news for pathologists and clinical laboratory managers. It would be necessary for the healthcare system to reimburse the increased volume of HIV and HCV screening tests at a level that would allow medical laboratories to recoup the fully-loaded cost of performing these assays.

On the other hand, increased demand for HIV and HCV testing would likely encourage in vitro diagnostic (IVD) manufacturers to develop simpler assays that could be used at the point of care and would cost less. In such a scenario, clinical laboratory professionals would be well-positioned to provide clinical consultations and other value-added services to the clinicians treating these patients.

—Pamela Scherer McLeod

Related Information:

U.S. health panel likely to make HIV tests routine

All baby boomers should get tested for hepatitis C: CDC

Dark Daily, “Frost & Sullivan Report Identifies Molecular Diagnostics as Fastest-Growing Sector of Clinical Pathology Laboratory Testing”

All Baby Boomers Should Be Screened for hepatitis C, Says CDC

 What is THE DARK REPORT clinical lab intelligence?

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